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IncellDx Gets CE Mark for HPV Assay

NEW YORK (GenomeWeb) – IncellDx today announced it received CE marking for it flow cytometry-based test for human papillomavirus.

The company also announced the launch of the test, which combines the quantification of oncogene mRNA overexpression, proliferation, and aneuploidy in one high-throughput assay. It quantifies the E6/E7 mRNA overexpression by RNA in situ hybridization and combines it with cell cycle DNA, which quantifies proliferation, which IncellDx said is a hallmark of transformation to cancer.

Further, the technology, dubbed IncellDx HPV OncoTect 3Dx system, does not destroy the cell, allowing for the identification of ectocervical cells, quantification of the percentage of cells that overexpress E6 and E7 mRNA, and cellular proliferation/aneuploidy in those cells.

IncellDx CEO Brucer Patterson said in a statement that the assay provides results in four hours from liquid-based Pap samples. "This test goes beyond the cervical cancer screening tests that answer whether a woman has an infection by a high-risk HPV type or not," he added.

Earlier in the month, IncellDx and Lebanese pharmaceutical product manufacturer BPI announced a deal to distribute InCellDx's products in the Middle East and North Africa.